(Last Updated On: December 30, 2019)

Authors: Mara Padilla Evangelista-Huber MD


Abstract: The Methods section of a clinical trial report should provide information on the design, conduct, and analysis of the trial. The essential information that must be found in this section includes details about:

Trial design:

· Description of trial design including allocation ratio


· Eligibility criteria of participants

· Setting and location of the trial


· Formulation, dosage, timing, and duration of any intervention given

· Characteristics of any placebo, including how it was disguised

· ‘Usual care’ given to a control group, if any

· Who administered the intervention


· Definitions of primary and secondary outcomes

· Who assessed the outcomes

· Frequency and timing of outcome measurements

Sample size:

· Key elements of the sample size calculation and interim analyses


· Sequence generation, allocation concealment, and implementation


· Who was blinded after assignment to interventions (participants, care providers, those assessing outcomes) and how it was done

Statistical methods:

· Reporting a treatment effect and the measure of uncertainty around the effect estimate

· Subgroup analyses, if any



Evangelista-Huber MP. Writing the methods section in a clinical trial report. J Phil Dermatol Soc 2019, 28(1), 10-14



methods, research, dermatology

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